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TGA Defends COVID-19 Vaccine Safety Amid Spike Protein Concerns

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During my session with the Therapeutic Goods Administration (TGA) at Senate Estimates in November, I questioned them about a number of concerns.

Does the TGA agree that spike protein is pathogenic in COVID-19 vaccines? Professor Langham clarified that the spike protein is not pathogenic and is designed to trigger an antigen recognition and antibody response. 

Has the TGA observed or seen reports of any adverse events related to the spike protein? Professor Langham responded that no such events have been observed, as the spike protein is quickly degraded by the body once it’s introduced s part of the mRNA vaccine.

What analysis did the TGA conduct regarding the spike protein’s suitability before vaccine approval? Professor Lawler agreed to provide detailed information on notice.

It has been demonstrated that spike proteins exert an inhibitory effect on the function of the angiotensin-converting enzyme 2 (ACE2), leading to dysregulation of the renin-angiotensin system. Is the TGA aware of this effect of spike proteins on ACE2 and on the renin-angiotensin system?  Professor Langham explained that while the spike protein attaches to receptors, it does not cause harm on its own. 

Is ‘long COVID’ the result of spike protein in the body coming from the Wuhan and alpha versions of COVID itself or is it from the vaccine products containing spike proteins, which are injected repeatedly in Australians?  Professor Lawler responded that there is no accepted evidence to confirm such a link.

Has the TGA received any applications for treatments to remove spike proteins from the body and has the TGA engaged with research institutions on this matter? Professor Lawler clarified that the TGA has not received such applications, does not commission research, and focuses on regulating therapeutic goods.

The TGA emphasised that the overall risk-benefit profile of COVID-19 vaccines remains positive.

    Transcript

    Senator ROBERTS: Thank you. Does the TGA agree that spike protein is pathogenic?

    Prof. Langham: Thank you for your question. The spike protein is not pathogenic. It does not contain any of the other parts of the COVID-19 vaccine that brings about a pathogenetic state. The spike protein is really there to encourage an antigen recognition and an antibody response by the body.

    Senator ROBERTS: Okay. I’ll move on. Has the TGA observed or seen reports of any adverse effects of COVID vaccination that may be associated with the likely effects of spike protein?

    Prof. Langham: As I said, the spike protein is not pathogenic. We’ve not seen any adverse events related to the spike protein, because—and we’ve discussed this previously—the spike protein is rapidly degraded by the
    body once it’s introduced as part of the mRNA vaccine.

    Senator ROBERTS: Really? Okay. What analysis did the TGA conduct regarding the suitability of spike protein in the COVID vaccines prior to approval? Could you please provide me with that material on notice.

    Prof. Lawler: I’m taking that question to be: what did the TGA know about spike proteins prior to approving the COVID vaccines? Is that a fair—

    Senator ROBERTS: I’d like to know what analysis you did regarding the suitability of spike protein in the COVID vaccines prior to approval, and I’d like that material on notice.

    Prof. Lawler: I’m happy to respond to that question on notice. We have responded to similar questions previously.

    Senator ROBERTS: Can you tell me about the analysis?

    Prof. Lawler: As I said, I’m happy to take that question on notice.

    Senator ROBERTS: Do you know about the analysis now? The question on notice is only if you don’t know something now.

    CHAIR: Senator, the official is well entitled to take a question on notice. It’s not about not answering the question; it’s about taking an answer on notice.

    Senator ROBERTS: Well, as I understand it, the guides to the witnesses include that if they want to take something on notice it’s only because they don’t know the answer now.

    CHAIR: Yes, or they need to qualify or check the information or they don’t have the extent of the information.

    Senator Gallagher: They don’t have the information with them to provide you a comprehensive answer, which is not unreasonable.

    Senator ROBERTS: Okay. Have you received any reports, data or discussion from your pharmacovigilance system highlighting concerns about spike proteins following the introduction of the COVID vaccines? If so, could you please provide that information?

    Prof. Langham: Again, I’m at a loss to understand the specifics of your question as to how our pharmacovigilance would relate to the specific aspect of the vaccine which is the spike protein. I think we can
    answer very clearly what our pharmacovigilance results have been for the vaccine itself. But as to the specific aspects of the spike protein, the reason the mRNA vaccines include the spike protein as the antigenic stimulus results from many years of research that had been undertaken in the US by the National Centre for Vaccines to develop mRNA vaccines.

    Prof. Lawler: And I’d just add to Professor Langham’s answer that the purpose of our pharmacovigilance and the way in which it monitors for and identifies to enable us to respond to emerging safety signals and trends is that it’s based on adverse events.

    Senator ROBERTS: That’s all it’s based on?

    Prof. Lawler: These are clinical events. So, there’s an expectation—indeed, an encouragement—that adverse events are reported, and these are reported on the basis of clinical nature. We also, as I mentioned previously, work with international partners on a network of pharmacovigilance activities that Dr Larter might like to speak to.

    Dr Larter: We continue to engage with our international regulatory counterparts to look at not only spontaneous adverse event reporting but also linked data, and many of the rich datasets that are available globally,
    to inform our safety monitoring. These processes enable us to identify emerging safety concerns well before we understand how they might be occurring, before the mechanisms of action are identified. That’s a strength. We don’t need to know exactly how they’re being caused to take regulatory action to ensure that the safety profile is up to date and available for treating health professionals.

    Senator ROBERTS: There has been a multitude of papers about potential health impacts from spike protein on the renin-angiotensin system in the human body. It appears to be basic to human health—if not the key system then certainly one of the key systems to health. Is it your testimony today that the COVID vaccines containing spike proteins are still perfectly safe.

    Prof. Lawler: We’re aware of the importance of the renin-angiotensin-aldosterone system. Professor Langham is a nephrologist. The reality is—I’m happy to come back if I’m wrong, but I don’t know whether we or any other regulator has ever said that a medication is perfectly safe. There are a number of processes that we follow in the assessment and market authorisation of a number of medicines. We have product information that clearly states the risks and potential adverse events—

    Senator ROBERTS: Who is that from? Who is the product information from?

    Prof. Lawler: The product information is produced—I guess, to the question, I’d like to say that we don’t maintain that the vaccine is perfectly safe. Every time we come here, we discuss with you the adverse events and the recognised and accepted potential adverse events. So, no, it’s not our position that the vaccine is perfectly safe. It is our clear position, and this is the clear scientific consensus, that the risk-benefit of COVID vaccines has been shown to be very safe and, in fact, the risk-benefit is significantly positive.

    Senator ROBERTS: Okay; I won’t explore that any further. It has been demonstrated that spike proteins exert an inhibitory effect on the function of the angiotensin-converting enzyme 2, ACE2, leading to dysregulation of the renin-angiotensin system. Is the TGA aware of this effect of spike proteins on ACE2 and on the renin-angiotensin system?

    Prof. Langham: It’s well known that the angiotensin receptor is important in how the virus exerts its effects on the body. As to what you are describing with the spike protein itself, on its own, it’s not able to cause any
    problems. It connects to the receptor, but there is nothing else there behind the spike protein. It’s the virus itself that does cause problems, and the receptor that that virus attaches to is absolutely the angiotensin receptor.

    Senator ROBERTS: Was the potential impact of spike proteins on the ACE2 receptor and the renin-angiotensin system considered as part of the analysis of the vaccines? I’d also like to come back again and ask: on
    whose advice do you take the product safety?

    Prof. Lawler: There are two questions there.

    Senator ROBERTS: Yes, there are.

    Prof. Lawler: I’d like to answer them in turn. Which one?

    Senator ROBERTS: The first one is: was the potential impact of spike proteins on the ACE2 receptor and the renin-angiotensin system considered as part of the analysis of the vaccines?

    Prof. Lawler: The process of the market authorisation and evaluation of medicines, including vaccines, is a comprehensive process that is based upon a significant dossier of information that goes to the safety, quality and efficacy of that particular medicine. In terms of whether that was a specific issue, I’m very happy to have a look at that and come back to you on that.

    Senator ROBERTS: On notice—are you taking it on notice?

    Prof. Lawler: Yes.

    Senator ROBERTS: Thank you. Recently, German doctor Karla Lehmann, in her peer-reviewed scientific paper published in the journal of the European Society of Medicine commented that spike protein is ‘uniquely
    dangerous’ for use in vaccine platforms—and this woman is generally pro-vaccine—because of the effects of spike protein causing ACE2 inhibition, leading to excessive angiotensin 2 and harmful overactivation of AT1R, the angiotensin 2, type 1 receptor. This analysis is supported by other research providing clear evidence of the pathogenic nature of spike protein and its unsuitability for use in vaccine platforms. Is the TGA aware of this review and analysis conducted by Karla Lehmann and her damning conclusions about the dangers of spike protein based vaccines?

    Prof. Lawler: I don’t have that article. It would be useful, obviously, to review that. I think it’s also worth noting that a lot of the theoretical conversations around spike protein are mechanistic in nature rather than
    supported by phenomenological or observational studies. So there are a lot of inferences drawn between a cellular mechanism and a clinical scenario that is very difficult to distinguish from the disease itself. Professor Langham, is there anything you would like to add?

    Prof. Langham: I guess I would just support those comments that, when the vaccine with the spike protein as the antigenic stimulus is trialled in clinical trials, the sorts of physiological derangement of the renin-angiotensin-aldosterone system that might be described is not seen. So we do not see activation of the renin-angiotensin-aldosterone system with the clinical trials in terms of understanding the specific safety signals that have come from them. It has been quite widely demonstrated that the vaccines themselves are very well tolerated.

    CHAIR: Senator, I’m due to rotate.

    Senator ROBERTS: I just have two more questions on this thread.

    CHAIR: Sure.

    Senator ROBERTS: Is ‘long COVID’ the result of spike protein in the body coming from the Wuhan and alpha versions of COVID itself or is it from the vaccine products containing spike proteins, which are injected
    repeatedly in Australians?

    Prof. Lawler: I don’t believe there’s accepted evidence to confirm that that’s the case.

    Senator ROBERTS: Has the TGA received any applications for treatments or protocols to remove spike proteins from the human body? Have you asked the National Health and Medical Research Council to advertise a
    grant for this purpose? Are you working with any university around this topic—anything at all—either to cure spike protein damage for long COVID, if it exists, or for vaccine injury?

    Prof. Lawler: The answer to the first question is not to my knowledge. The answer to the second question is that it’s not the role of the TGA to commission research from the National Health and Medical Research Council. And the answer to the third question is it is not the role of the TGA to generate knowledge; it is the role of the TGA to regulate therapeutic goods.

    Senator ROBERTS: That’s the end of my questions on COVID spike protein. I have two more sets of questions.

    CHAIR: Do you mean for the TGA?

    Senator ROBERTS: Yes, for the TGA but on other topics

    /8 Comments/by

    Questions Raised on Safety of Infanrix Hexa Vaccine

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    These questions are about Infanrix Hexa and SIDS and are based on information contained in Freedom of Information documents 3828 (document 9) and 1345 (document 1). This vaccine is approved to protect against nine different strains of six diseases: Diphtheria, Tetanus, three strains of Pertussis, Hepatitis B, Influenza type B, and three types of inactivated Polio viruses. Each vial containslactose, sodium chloride, aluminium chloride, hydroxide, aluminium phosphate, phenoxyethanol medium, potassium chloride, polysorbate 20 and 80, formaldehyde, glycine, sodium phosphate, dibasic dihydrate, potassium phosphate monobasic, neomycin sulfate, polymyxin B sulfate and 2-phenoxyethanol. There is a lot happening in that single jab.

    All of these chemicals are given to six-week-old babies, again a month later and then again as a booster, in many cases. There are 17 reported deaths on the DAEN (Database of Adverse Event Notifications) from this product and another 26 reported deaths on your internal Adverse Event Management System (AEMS) going back to 2010. The report from 2010 is that the child died on the same day as the injection, with no other suspected medications or health issues. The child was injected and then died. Why is that death still on the AEMS and not on the public DAEN after 14 years?

    Once again, the public servant feigned not understanding the question before deflecting and failing to answer, offering instead to take the question on notice. The reason our vaccines are considered safe and effective is because cases where they were not safe are covered up, as is happening here. There is no reason for the specific case I am asking about to still be withheld from the public. The facts of the matter were clear in 2010 and they are clear now: the vaccine is full of harmful substances and killed that child.

    Transcript

    Senator ROBERTS: My next set of questions are about Infanrix hexa and SIDS. My questions are on the vaccine Infanrix hexa using information contained in freedom of information 3828 document 9 and freedom of
    information 1345 document 1. Constituents are raising this issue with me. This vaccine is approved to protect against nine different strains of six different diseases, and, for brevity, these are diphtheria, tetanus, three strains of pertussis, hepatitis B, influenza type B and three types of inactivated polio viruses. Each vile contains lactose, sodium chloride, aluminium chloride, hydroxide, aluminium phosphate, phenoxyethanol medium, potassium chloride, polysorbate 20 and 80, formaldehyde, glycine, sodium phosphate, dibasic dihydrate, potassium phosphate monobasic, neomycin sulfate, polymyxin B sulfate and 2-phenoxyethanol. There is a lot happening in that single jab.

    You give all of those chemicals to six-week-old babies, then again a month later and then again as a booster, in many cases. To my question: there are 17 reported deaths on the DAEN—that’s the Database of Adverse Event Notifications—from this product and another 26 reported deaths on your internal Adverse Event Management System, AEMS, going back to 2010. The report from 2010 is that the child died on the same day as the injection and there were no other suspected medications or health issues. The child was injected, and he died. Why is that still on the Adverse Event Management System and not on the public Database of Adverse Event Notifications? Isn’t 14 years long enough to have processed the report?

    Prof. Lawler: So there are two questions there. On the first, I think it’s going to be very difficult for us to give you a satisfactory answer now on the basis of a 14-year-old report, so we will have to take that on notice as well. And the second question, sorry?

    Senator ROBERTS: Why is the report still on the Adverse Event Management System and not on the public Database of Adverse Event Notifications?

    Prof. Lawler: Was that the first or the second question?

    Senator ROBERTS: The second one.

    Prof. Lawler: Then the answer is probably the same.

    Senator ROBERTS: Okay; 10 of the 28 deaths on the Adverse Event Management System record cause of death as Sudden Infant Death Syndrome, and three on the Database of Adverse Event Notifications. Can you
    confirm that, in a limited number of cases, routine childhood vaccinations have caused Sudden Infant Death Syndrome—SIDS?

    Dr Larter: It’s very important to remember that the reporting of an adverse event or death to the TGA does not necessarily mean that the vaccine caused the death, or even that the reporting doctor necessarily considered that the death was caused by the vaccine. We strongly encourage all consumers and health professionals to have a very low threshold for reporting suspected adverse events, even if there is only a very small chance that the vaccine was the cause. To date the TGA has not identified SIDS as an adverse event associated with Infanrix.

    Senator ROBERTS: There are 14 other cases of babies dying within three days of injection with this product, including three others that died on the same day. Why hasn’t the TGA investigated these deaths, and why are they still hidden on the Adverse Event Management System, which I understand—correct me if I’m wrong—is internal?

    Dr Larter: That is correct. The TGA’s Adverse Event Management System is the database that contains all the detailed information regarding adverse events reported to the TGA. The Database of Adverse Event
    Notifications for medicines is our public database, which includes de-identified adverse event information. The vast majority of reports made to the TGA are included in the public database. However, where the case has been rejected or where it’s a duplicate, these cases are not published. In terms of why an individual case is not included in the public database, we would need to take those questions on notice.

    Senator ROBERTS: Could you also tell me then, as part of the other part of the question, why the TGA hasn’t investigated these deaths?

    Dr Larter: Again, we can confirm on notice. The TGA does have robust processes in place for investigating reported deaths after vaccination, as we’ve previously advised. We work very closely with state and territory
    jurisdictional immunisation committees and public health units to investigate any death that’s reported to us after vaccination. So, while I cannot confirm the details of the individual cases, they will have been investigated by the TGA.

    Senator ROBERTS: We don’t want personal details. Here’s your ideal opportunity to show off the TGA now, on notice. There are 14 other cases of babies—

    Prof. Lawler: Sorry, can I just respond? It is actually very difficult to give a fulsome response on cases that are, in some instances, 14 years old.

    Senator ROBERTS: Well, perhaps you could tell us why you haven’t done the response.

    Prof. Lawler: I would hope, Senator, that you would not want us to be providing information to you without the information that we require. So I understand—

    Senator ROBERTS: What do you mean by that?

    Prof. Lawler: What I’m saying is that I’m assuming that you would not want us to prevaricate or invent information simply for the purposes of providing an answer. As you said earlier yourself, an appropriate reason
    for taking a question on notice is because we don’t have the information in front of us.

    Senator ROBERTS: That’s fine.

    Prof. Lawler: So Dr Larter has endeavoured to make clear the processes that we do follow for the purposes of giving you specific information about some specific cases that you have raised. We will need to take that on notice.

    Senator ROBERTS: Absolutely. That’s fine. That’s in accordance with the witness guide. There are 14 other cases of babies dying within three days of injection with this product, including three others that died on the same day. Why hasn’t the TGA investigated these deaths? Sorry, I’ve asked that question. But 29 of the deaths were male babies and 14 were female. Have you investigated why the hexa product is twice as likely to kill male babies as female babies?

    Prof. Lawler: I’ll go to Dr Larter in a moment. The assertion or implication that you make, that it is twice as likely to kill babies, I think is an inappropriate statement to make, and it’s not reflective of an understanding of vaccine safety or statistics.

    Dr Larter: Again, reporting of an adverse event does not mean that that adverse event is causally related to the vaccine. We do investigate all deaths and adverse events following immunisation.

    Senator ROBERTS: Thank you for that. That finishes my second set. I’d like to have a third set after Senator Rennick.

    CHAIR: You’ve still got a couple of minutes.

    Senator ROBERTS: I don’t want to start the third set and then leave it halfway through

    /by

    Global Health Emergency or Corporate Payday?

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    The World Health Organisation (WHO) has declared Monkeypox a global public health emergency, triggering emergency powers to drive vaccine sales that benefit big pharmaceutical companies with ties to the organisation. This decision serves corporate interests rather than public health. Regulatory agencies that are meant to protect the public fall under undue influence from the industries they regulate. The WHO is a corrupt organisation that is designed to funnel taxpayer money to its billionaire donors. Australian taxpayers gave $30 million to the WHO last year, likely as a show of loyalty.

    Transparency is lacking. Major donors include Gavi, a vaccine alliance funded by corporations tied to predatory giants like BlackRock and Vanguard, who also own large shares in pharmaceutical companies. The WHO’s Monkeypox emergency, declared solely by its director-general, Tedros Ghebreyesus, highlights the unchecked power of the position. This decision created a market for four already-approved vaccines linked to companies backed by BlackRock and Vanguard, ensuring massive profits for their shareholders. A new Monkeypox vaccine is expected soon, likely fast-tracked by compromised regulators like Australia’s Therapeutic Goods Administration (TGA).

    The WHO previously tried to raise alarm over Monkeypox but found little public concern, so they rebranded it as “Mpox” to push vaccine sales. This benefits the predatory billionaires who control vaccine companies, funnel money to Gavi and the WHO, and fund political parties, including Australia’s Liberal and Labor parties. Recent revelations show Anthony Fauci concealed plans to engineer a more deadly and highly transmissible Mpox virus. This “gain-of-function” research has pandemic potential and should be stopped immediately. It’s troubling that Australia’s CSIRO was involved in gain-of-function research for COVID-19, yet faces no consequences.

    The WHO and the TGA have failed in their regulatory duties, serving political agendas rather than public interest. During COVID, the TGA prioritised government control over public health, and there are concerns the same will happen again with Mpox. Every Monkeypox case should be verified through public lab tests, especially as redacted data was used to justify COVID measures that harmed public health.

    The time of blind trust in the WHO’s narrative is over; it’s now the age of ‘prove it’.

    Transcript

    The UN’s World Health Organization, the WHO, has declared monkeypox a public health emergency of international concern. This triggers WHO emergency powers to drive vaccine sales to financially benefit big pharmaceutical companies that donate to the WHO through their other commercial and ownership interests. The first thing a house of review like our Senate should do is ask, ‘Is this a legitimate decision?’ The answer is: it is not, no. The UN WHO has succumbed to regulatory capture—a troubling development in governance. That may plunge Western society into serfdom under large corporations. 

    Regulatory capture occurs where a regulatory agency mandated to oversee and enforce rules to protect the public interest ends up under undue influence from companies with vested interests such as the entities it’s meant to regulate or special interest groups. This can result in the agency making decisions that prioritise the interests of these parties over the broader public interest. The New South Wales government lists six areas for regulatory capture: adherence to public interest principles; organisational culture; structure; processes; transparency; and staff experience. The WHO fails all six. 

    I’ve often spoken about the corruption, cronyism and illegal behaviour of the World Health Organization; some of my WHO speeches are on my website. The WHO fails to hold staff accountable for misbehaviour, including rape and sexual assault. Its own investigators conclude the WHO is ‘rotten with rapists’—their words. It is a failure of organisational culture and of staffing quality. The WHO is a corrupt organisation whose decisions benefit its billionaire sponsors with substantial health interests. The scam is simple: take a disease that’s around for generations—firstly the flu, and more recently bird flu and now monkeypox; plant scary stories in a media desperate for clickbait articles; use the media driven fear to declare a pandemic; and then—payday!—mandate vaccines financially benefiting the billionaires that funded the media scare. This betrays the public interest. 

    The WHO is a con, a fraud and a criminal enterprise designed to transfer wealth from taxpayers into the pockets of their billionaire donors and owners. It is an organisation to which Australian taxpayers gave $30 million last year despite them having $8 billion in financial assets; that donation was likely more about fealty than financing. Identifying the WHO’s donors is difficult since its annual accounts show 32 per cent of donations as ‘other’—another failure of transparency. One of the WHO’s major donors is Gavi, the globalist vaccine alliance of international academics, bureaucrats and pharmaceutical companies funded through corporate donations from companies whose share registers feature investment funds like BlackRock and Vanguard. They feature on big pharma share registries; they own big pharma. If Australia had racketeering laws this arrangement would be illegal. This is a failure in structure. 

    The monkeypox declaration came from the WHO director-general, Tedros Ghebreyesus, acting alone. The process for making such an important decision is not meaningfully regulated and gives Ghebreyesus too much power to direct a worldwide health response. This is a failure of process, and it’s deliberate. The proclamation is designed to create an international market for new monkeypox vaccines. The WHO already have four approved vaccines for monkeypox: cidofovir, distributed through Pfizer; brincidofovir, manufactured and distributed through Chimerix, whose controlling shareholders include Vanguard and predatory wealth fund cronies; TPOXX, from Siga Pharmaceuticals, with shareholders BlackRock and Vanguard; and ACAM2000 from Emergent Biosolutions, whose largest shareholders are—wait for it—BlackRock and Vanguard. With these drugs the world’s predatory billionaires have decided it’s time for another fundraiser. All four drugs are off-label use—so, any day now, expect a killer new vaccine for monkeypox to be given the hosanna palm frond parade through our disgraced regulators like Canberra’s Therapeutic Goods Administration, the TGA. 

    The WHO tested this scam a few years ago with a minor media fear campaign that discovered the public didn’t take something called monkeypox seriously. So they rebranded it as mpox. Amusingly, they claimed the name monkeypox was insulting to monkeys; monkeys have feelings too, you know! So mpox is monkeypox rebranded to sell more vaccines from vaccine companies who funnel the profits to the world’s predatory billionaires—those same billionaires who own the corporations that donate to Gavi and the WHO as well as fill the coffers of political parties around the world, including massive donations to both cheeks of the Liberal-Labor uniparty in this country. 

    Last Tuesday, American congressional investigators revealed that, for nearly nine years, Anthony Fauci concealed plans to engineer a pandemic-capable mpox virus with high transmissibility and a case fatality rate of up to 15 per cent. That’s homicide. The gain-of-function project proposed through NIAID in America from virologist Bernard Moss was to splice genes conferring high pathogenicity from the clade I virus into the more transmissible clade II virus. The new chimeric virus or combined virus could have retained up to a 15 per cent fatality rate and a 2.4 reproductive rate—a measure of transmissibility—meaning, on average, every sick person could infect up to 2.4 other people, giving it pandemic potential. It’s marvellous, what it’s designed to do! 

    We know gain-of-function research produced the COVID-19 virus. Is this monkeypox outbreak also man-made? 

    Gain-of-function research serves no useful purpose and should be terminated immediately. It’s deeply troubling that Australia’s CSIRO admitted and bragged about its involvement in gain-of-function research that produced COVID-19. And now an online meme simply says: ‘They’re doing it again because you didn’t punish them last time.’ That’s truth indeed. 

    The WHO fails all six elements of regulatory capture and so does Australia’s Therapeutic Goods Administration, the TGA. The TGA is not acting in public interest, which former New South Wales deputy ombudsman Chris Wheeler considers fundamental to representative democratic government. The TGA may claim that, during COVID, it was caught between the parliament, its direct employer, and the wider public. It chose to serve the government’s need for air cover for controls decided on political, not medical, grounds. The TGA should have read the findings of the 1990 WA Inc royal commission, which found: 

    The institutions of government and the officials and agencies of government exist for the public, to serve the interests of the public. 

    That’s clear. Yet, during COVID, the TGA chose a different path: to support their own agency, to the detriment of the public. What will the TGA do this time, with monkeypox? 

    Monkeypox is transmitted through direct contact from sexual activity or intravenous drug use. A Philpot scientific study found 98.7 per cent of infections resulted from gay male sexual transmission. Transmission can occur through direct personal contact of the infected site. Infected animals can spread the disease. Asymptomatic spread, though, is, like COVID, an assertion with no evidence. The clade Ia variant of monkeypox can affect children. The clades currently circulating, though, clade Ib and II, have not been proven to infect children. 

    Australia has two monkeypox vaccines approved for over-18s. Both are off-label repurposed drugs approved for smallpox. JYNNEOS from Bavarian Nordic uses cidofovir, which I mentioned earlier, as the active ingredient. Bavarian Nordic have an application in to America’s Food and Drug Administration to give this vaccine to children aged 12 to 18 and are in early testing to support their application to extend use to children aged two and above—two and above! Why does a child need a vaccine against a disease that’s predominately only transmitted through sexual contact or intravenous drug use? The case for a monkeypox vaccination program must be a very high bar for any person who does not engage in risky sexual activity. 

    TGA’s website data from the 2022 monkeypox round of vaccinations in Australia shows 3,163 adverse events per 100,000 vaccinations—a staggeringly high three per cent. I note a study published in the journal Frontiers in Medicine, with authors from the University of New South Wales, entitled ‘Autoimmune blistering skin diseases triggered by COVID-19 vaccinations: an Australian case series’. This report found that COVID-19 vaccination either caused the recipient to develop autoimmune blistering disease or made the recipient’s existing condition worse. The cases are extremely rare, and, for once, I can agree with the TGA. I alert Australia to the chance that these outbreaks of a related disease could be mistaken for monkeypox. I note that autoimmune diseases and shingles—that is, herpes zoster—can intersect, and both are side effects of the COVID vaccines. If the Senate is going to be called on to support a monkeypox response, then it’s essential every case is verified through publicly disclosed laboratory testing. 

    Page after page of redacted data was used to support COVID measures and the damage to public health is undeniable. It’s homicide. ‘Safe and effective’ was not one lie; it was two. People are not believing the UN World Health Organization mpox narrative. The time for blind trust is over. We’re now in the age of ‘prove it’. 

    /by

    Public Hearing: Vaping Reforms Bill 2024


    The Albanese government is legislating to prohibit vaping for recreational use, as an aid to quitting smoking and to sustain smoking cessation efforts. I’ve been receiving numerous messages from Australians who have successfully kicked the smoking habit through vaping. They now either vape a herbal solution to combat the physical habit of smoking, or have completely quit. The Labor government’s move to ban vaping contradicts the international vaping experience.

    Health authorities in the UK have found that vaping is a safer alternative to smoking and provides an effective pathway for smokers to quit.

    The measures in the bill will, however, allow individuals wanting to quit or who are in the process of quitting, to obtain a prescription from their doctor for a vape. The use of this provision is being disingenuous, as many Australians who are attempting to access vapes to aid them in quitting are finding that either their doctor refuse to prescribe a vape, or the pharmacy does not stock them. 

    Additionally, the costs have surged as demand s gone up exponentially as volume has fallen, and as medical establishments take a much larger share of the sale than a tobacco/vape retailer did.

    Although there’s concern about children, it’s always been illegal for minors to vape, just as it’s always been illegal for children to smoke cigarettes. While vaping poses less risk to minors than smoking, the ideal scenario is for parents and guardians to prevent their children from engaging in either. The idea that vaping serves as a gateway to smoking is wrong and is not supported by experiences in many other countries like the UK that have legalised vaping.

    The Minister’s actions will force vaping underground, evidenced by recent incidents where two vape shops were targeted by organised crime. Illegally supplied vapes will likely be adulterated with addictive substances, manufactured cheaply and with little regard for safety.

    This is a health disaster waiting to happen and is entirely foreseeable.

    One Nation supports the regulation and licensing of vapes and vaping products exclusively for adult consumers.

    Transcript

    Senator ROBERTS: Thank you, Chair, and thank you all for being present today. Professor Buchanan, can I confirm your involvement with the University of Wollongong School of Health and Society?

    Prof. Buchanan: Yes.

    Senator ROBERTS: Thank you. The University of Wollongong school of health receives substantial grants from the National Health and Medical Research Council year on year. Is your testimony today completely
    independent of the people who fund you?

    Prof. Buchanan: I am not funded, Senator Roberts, by the University of Wollongong. I have an honorary position and I receive no funding from the University of Wollongong.

    Senator ROBERTS: The university is associated with the Global Challenges Project, which is funded by Open Philanthropy, an organisation that campaigns against smoking specifically by taxing it out of reach of
    everyday Australians. Do you support increased taxation rather than vaping as a means of smoking reduction?

    Prof. Buchanan: Sorry, Senator; in the last part of your question I got a bang on the microphone and I didn’t catch it.

    Senator ROBERTS: Sure. Do you support increased taxation rather than vaping as a means of smoking reduction?

    Prof. Buchanan: We support a comprehensive approach to reducing tobacco. Excise is one of those approaches, and there is a range of others. They are all outlined in the National Tobacco Strategy and we support
    all of the measures in the National Tobacco Strategy.

    Senator ROBERTS: Cancer Research UK have a 100 per cent opposing view to yours. Their analysis of the use of e-cigarettes, ones that are registered with the UK Medicines and Healthcare products Regulatory Agency, the equivalent of our TGA, states this: Lots of people want to know about the health effects of e-cigarettes … Many studies show that vaping is far less harmful than smoking. This is because e-cigarettes don’t contain cancer-causing tobacco, and most of the toxic chemicals found in cigarettes are not in e-cigarettes. … … … There is no good evidence that vaping causes cancer. … … … Because vaping is far less harmful than smoking, your health could benefit from switching from smoking to vaping. And you will reduce your risk of getting cancer. Who is right — Cancer Research UK or the Australian Cancer Council?

    Prof. Buchanan: What we are all saying is that we want to see people who smoke stop smoking, because it is incredibly risky. If some smokers can benefit in quitting by using e-cigarettes then we would support that. We have never not supported that. But we would like to see that support provided through a healthcare professional who can enable that person to make the right clinical decisions to manage their nicotine addiction and then to move forward by helping them to quit vaping. In many of the studies where people have used vaping to quit, we’ve seen an increase in the number of people who dual use rather than quit products altogether, and that is not a good outcome.

    Senator ROBERTS: I’ll come to what you’ve said in a minute. Johns Hopkins Medicine also maintains that: Vaping is less harmful than smoking. … … … Regular cigarettes contain 7,000 chemicals, many of which are toxic. … … … … vaping exposes you to fewer toxic chemicals. Professor Buchanan, why are you supporting a bill that exposes smokers to more toxic chemicals than vaping?

    Prof. Buchanan: We are not supporting a bill that increases people’s exposure to anything. What we are supporting are ongoing comprehensive tobacco control measures in this country which have proven to be incredibly effective in reducing smoking rates. At the same time, for those smokers who are struggling to quit— and we need to remember that it is a very small percentage of the population—we want them to get the help that they need under the care of a healthcare professional.

    Senator ROBERTS: We are on the same track now, then. Professor, the United Kingdom National Health Service says of vaping: Nicotine vaping is substantially less harmful than smoking. It’s also one of the most effective tools for quitting smoking. That is what I think you want. It says: Vaping is not completely harmless and we only recommend it for adult smokers, to support quitting smoking and staying quit. Is the Cancer Council of Australia out of step with the science?

    Prof. Buchanan: I think we have already addressed that. What we want to see for people who are looking to quit smoking are evidence based approaches to quit. We know that most Australian people who are looking to quit smoking will quit unaided. For those who need support and cessation aids to quit—and that is not the vast majority of smokers; in fact, the vast majority of smokers who quit smoking do so unaided—there is a strong evidence base of safe, effective, regulated medicines in Australia. E-cigarettes are not one of those and so people should be receiving support for using those products under the care of a healthcare professional.

    Senator ROBERTS: My electorate office has been receiving many contacts from real Australians complaining about this measure and saying how much vaping has improved their lives, reduced their nicotine dependency and even helped them quit smoking entirely. Are these people lying or are you protecting the $500 million ‘quit smoking’ industry from a product internationally proven to reduce smoking?

    Prof. Buchanan: We have not said anywhere that this product will not help some people to quit smoking. We do believe that it well. But because the nature of the product is that it is not a safe product people are best placed to work with their healthcare professional—

    Senator ROBERTS: It’s stated that two out of three—

    CHAIR: We need to let the witness finish.

    Prof. Buchanan: I do take objection to your implication that we are somehow protecting an industry. We are actually about preventing ill health from smoking and also associated with vaping.

    CHAIR: Thank you, witnesses, for staying longer than you were allocated. We appreciate your involvement in our committee. If you have taken questions on notice, we are asking for answers back very quickly—by COB Monday 6 May.

    /6 Comments/by

    Replace Health Pharmacrats With People-First Health Care

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    One thing that has come out of the COVID response is how it’s exposed the pharmaceutical industry to more scrutiny from the public than ever before. More questions have been raised about the Therapeutic Goods Authority (TGA) and our Health Pharmacrats than ever before. Yet, what is the alternative?

    In this parliamentary speech, I put it on record that we must look at the influence of pharmaceutical companies on the education system for medical professionals, and the relationships between pharma giants and former health department executives. The toxic, inhuman killer ‘pharmaceutical only’ model is failing Australian taxpayers. People are dying needlessly.

    As an example, Albicidin is a natural antibiotic with clear potential to become our leading antimicrobial. It’s proven to not create resistance. Albicidin could be, and most likely is the answer to antimicrobial resistance. There are many others, but they don’t get patented. They don’t receive sponsorship and therefore they don’t get approved.

    It’s time for an entirely new medical paradigm. One that puts humans first, not big pharma.

    Antimicrobial resistance is the new climate change, allowing for control over agriculture, medicine and household and industrial cleaning, in the name of reducing use of antimicrobials. That’s why an alternative solution, using an antimicrobial that doesn’t cause antimicrobial resistance, is being ignored and quietly buried. It’s to protect globalist profits and to control people – and to hell with human and animal health and safety!

    Globalists WANT control. Globalists NEED control to complete their agenda.

    Australia needs a customer consumer advocate, or natural product advocate, to advance natural products that can’t be patented, yet are safe and effective treatments — products to be listed under Schedule 4 and offered under the PBS as frontline medicines. Not watered down products sold in supermarkets as complementary medicines so that their efficacy can plausibly be dismissed.

    Instead of advancing people-first health care, our Pharmacrats are actively promoting mRNA vaccines and medications to the commercial benefit of big pharma. This is caused by “the patent cliff”, which refers to the expiration of patents on popular drugs, leading pharmaceutical companies to face intense competition from generic drug makers, dramatically reducing their profits. The new mRNA technology allows big pharma to replace off-patent drugs with newly patented mRNA drugs at prices that guarantee their profits for the next 30 years. Our health authorities are actively promoting this solution to the patent cliff, despite the myriad of adverse health outcomes from the mRNA vaccines.

    Why? These are important matters that can only be answered by a Royal Commission.

    What should not wait for a Royal Commission is a system to incorporate affordable, natural remedies into our health approval process. This could be implemented immediately if the Pharmacrats were interested in providing people-first health care.

    Transcript

    Where’s the scrutiny on our health authorities? During COVID, drugs were rushed through that would never have been approved on safety and efficacy grounds, such as molnupiravir and remdesivir. Last year, these two inhuman pharmaceuticals cost taxpayers $1 billion. Alternatively, tried and tested drugs that are out of patent could have been used for a fraction of the price. Remember that our authorities and the mouthpiece media called ivermectin ‘horse paste’. The statist Left rushed to demonise anyone who defended ivermectin, because the control side of politics—the so-called Left—loves to follow orders. Ivermectin is a Nobel-Prize-winning antiviral for humans. Over 40 years, it has saved millions of lives. Around the world, it’s now been proven safe and effective as an early-stage treatment for COVID, as it always was.

    Our health authorities demonised ivermectin to prevent early-stage treatment of COVID in order to build demand for an untested novel mRNA vaccine. How many died because of the long-term strategy that our health authorities followed and pushed—a strategy to use COVID as a cover to introduce a class of mRNA drugs that the public would have rightly baulked at and rejected? How many died from the side effects of mRNA technology—technology that was not tested in Australia and was not tested off the production line, for which the method of production was changed after overseas testing and approval and the fake trials were at best shambolic and at worst criminally negligent?

    Why would our health authorities tolerate this? Simply because of a thing called the patent cliff. Pharmaceutical companies are profitable because they develop a new drug and then get a patent, exclusive sale of the drug for 25 years. Drug companies can afford to put that drug through the approval process because once it’s approved they add the approval cost to the selling price—kerching, kerching!

    The system of drug patents has created a $2 trillion industry whose tentacles of influence extend to political parties, who happily accept donations, and to health authorities. Their tentacles extend to the USFDA and Anthony Fauci’s National Institutes of Health, who hold patents on drug processes they license to big pharma in return for hundreds of millions of dollars in personal royalties. Their tentacles extend to the World Health Organization, the United Nations and the World Economic Forum, whose young global leaders sit in this parliament.

    This is influence that our healthy authorities cultivate while coveting lucrative careers in the pharmaceutical industry. For example, just eight months after approving Pfizer’s untested COVID injections, Professor John Skerritt, former head of the Therapeutic Goods Administration, the TGA, is now on the board of the pharmaceutical industry lobby group Medicines Australia. This isn’t the normal operation of a free-enterprise system that One Nation would support; this is a cabal of greedy, unprincipled, evil individuals treating everyday citizens as cash cows. They want everything you have for themselves, including your health.

    The patent cliff is upon us. There’s increasing urgency—desperation—in the measures being rammed through government. Two-thirds of the revenue is from drugs being sold to you that are out of patent now or will go out of patent over the next five years. That threatens big pharma’s harvesting of humans for profit. Modern drugs, once out of patent, can be made for cents per tablet. India specialises in that. Australia used to, and we can do it again. The patent cliff threatens the entire pharmaceutical industry and stops the ability of chemical pharmaceuticals to do better than they do now, in terms of profit.

    From where are the new patents going to come? I’m glad you asked, Mr Acting Deputy President: from mRNA of course. There are 400 new mRNA vaccines and drugs currently under development. Such is the expected volume of these things that two manufacturing plants are being prepared here in Australia. Our health authorities decided to press ahead with mRNA technology to save the pharmaceutical status quo—the pharmaceutical gouging of people to extract exorbitant profits. Patient harm apparently no longer matters.

    Last week, a study of 99 million COVID-jab users, including in New South Wales and Victoria, found the product was not safe. The study was published by Elsevier, for more than 140 years the world’s leading scientific publisher and data analytics company. The study showed the following conditions were occurring above baseline levels: brain and spinal cord swelling, up 380 per cent; blood clots, up 320 per cent; Guillain-Barre syndrome, up 250 per cent; and myocarditis, up 278 per cent for Moderna and up 350 per cent for Pfizer. After a second injection, myocarditis was up a damning 610 per cent and pericarditis was up 690 per cent. I told you so four years ago. Many good people warned that COVID products were not tested, that they were experimental, and that forcing them on the general population was an insane, inhuman abuse of government power. Now look at those figures. It’s another area for a royal commission to investigate.

    It’s time for an entirely new medical paradigm in this country and throughout the West. Pharmaceutical companies are embracing mRNA as their saviour because it can be patented. They can charge whatever they want for it, and compliant health bureaucrats like our TGA, acting out of self-interest, protect pharmaceutical companies from financial harm. The expert medical advice the TGA relies on comes either directly from drug companies or from advisers who have worked for big pharma, who have accepted research grants or sponsorship from big pharma, or who covet doing so in the future. After all, $29-million Sydney harbourside mansions don’t just buy themselves.

    These are things that make for a royal commission. One thing that should not wait for a royal commission is a system for getting cheap, natural remedies into our health approval system. Australia needs an office of the consumer advocate to oversee complaints and the harm bureaucrats cause—bureaucrats who appear incapable of acknowledging odious and obvious adverse events. We need a customer consumer advocate or a natural product advocate to advance natural products that can’t be patented but are safe and effective treatments—products to be listed under schedule 4 and offered under the PBS as frontline medicines, not watered down and sold in supermarkets as complementary medicines so their efficacy can be dismissed. Albicidin, for example, is a natural antibiotic with clear potential to become our leading antimicrobial. It’s proven to not create resistance. Albicidin could be the answer, and highly likely is the answer to antimicrobial resistance.

    Antimicrobial resistance is the new climate change, allowing for control over agricultural, medicine, and household and industrial cleaning in the name of reducing use of antimicrobials. That’s why an alternative solution, using an antimicrobial that doesn’t cause antimicrobial resistance, is being ignored and quietly buried: to protect globalist profits and to control people—and to hell with human and animal health and safety! Globalists want control. Globalists need control to complete their agenda.

    Take another example: blushwood is an Australian native berry. It was shown, in a 2014 test, to kill skin cancer in just 10 days. Did our health authorities rush to understand this plant and bring a potentially lifesaving medication to market? No; they did not. Another one: conolidine is a natural treatment for severe pain. Ignored! Natural remedies include cannabis. Senator Pauline Hanson has led way, advocating for medicinal cannabis since 1996. I joined her, and now there are others.

    A recent paper pointed out that natural products work differently to chemical products, yet our system for understanding and testing substance efficacy is geared to chemical drugs. The paper and system offer a new way of measuring efficacy that confirms plants like cannabis and conolidine do work, and explains how they work. The truth is this: currently only when a product is patented and presented as the TGA on a plate, ready for the TGA’s rubberstamp, does it enter our pharmaceutical system. I urge the Minister for Health and Aged Care to introduce a consumer natural products advocate to provide much needed supervision and accountability over our health authorities. Failing that, I ask the Greens to consider if the agency they’re establishing with the Legalising Cannabis Bill would be better suited to handle natural medications in general—those that the TGA refuse to handle in addition to cannabis.

    I’m not offering medical advice on the examples I’ve used in this speech; I’m asking why the health department and medical schools first response is to the scalpel and the prescription pad instead of natural medications that cost a fraction of the price. We must have an independent office in the TGA with the budget to sponsor natural alternatives through the safety, testing and efficacy stages, and to have these promoted to doctors who most likely have never even heard of them.

    We must look at the influence of pharmaceutical companies in the education system for medical people, in their relationship with former health department executives and their influence through advertising and sponsorship. The toxic inhuman killer ‘pharmaceutical only’ model is failing Australian taxpayers. People are dying needlessly. Stop so-called health authorities committing homicide, child homicide, infanticide. As a servant to the people of Queensland and Australia, I say call a royal commission now and make an immediate start on the obvious reforms to our health administration that we need.

    /6 Comments/by

    TGA and Pharmaceutical Interests Are Too Close

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    I questioned the Minister and the Senior Health Department Bureaucrats about the behaviour of former TGA head, Professor Skerritt, who spent 11 years in charge of the TGA before resigning last year and soon after accepted a position on the board of Medicines Australia. This is the peak body representing and lobbying for pharmaceutical companies. The deputy chair for instance is the Head of Pfizer in Australia.

    The answers I received in this session highlight that former senior bureaucrats like Professor Skerritt only have one rule to follow—they can’t lobby the Government for 12 months. That’s the only rule applying to former senior health officials. That’s not good enough.

    Professor Skerritt and the TGA spent the COVID years dismantling and re-assembling Australia’s drug assessment process to provide drug companies with streamlined approvals, free from the need to provide testing of brand new drugs. Approval has gone from active inquiry to a desktop review of provided literature, before rubber-stamping. This appointment does not pass the pub test.

    A Royal Commission must look into the TGA’s behaviour during COVID and the changes made to our drug approval process, without public debate.

    Transcript

    Senator ROBERTS: Thank you for being here again today. Professor Skerritt’s career includes a period as deputy head of the Department of Health and Aged Care and as head of the Therapeutic Goods Administration. Eight months after leaving the TGA, Professor Skerritt has been appointed to the board of a lobby group, Medicines Australia—in fact, the leading pharmaceutical industry lobby group. The deputy chair of that organisation is the Managing Director of Pfizer. There are other members on the board who are heads of other companies. As head of the TGA, Professor Skerritt introduced the mRNA into Australia and provided authorisation—without testing, as he admitted to me—creating a whole new industry that he is now working in. Does this sound like an appropriate arrangement to you? It sounds like a massive conflict of interest to me. It’s just brazen, like the rules don’t apply to him—or are there no rules?

    Mr Comley: I don’t know whether Professor Lawler or Ms Balmanno want to comment. There are rules in terms of former public servants and what they can do, but those rules are largely limited to lobbying activities related to their previous departments. There’s not a broader prohibition on their activity in related areas that they’ve worked in the Public Service.

    Senator ROBERTS: He has joined the most significant, powerful lobby group for the pharmaceutical sector, which he was previously regulating.

    Mr Comley: As long as he’s not undertaking lobbying activity to us—I think it’s in a 12-month period—that is appropriate.

    Ms Balmanno: His obligations in relation to confidentiality of any information gained while in the Public Service continue to apply.

    Senator ROBERTS: Let’s unpack that a bit further. This is what Medicines Australia’s latest annual report said about Professor Skerritt: After 11 years leadership of the TGA, Prof John Skerrit retired in April Professor Skerritt has been a cornerstone of our health system for many years. … Medicines Australia and member companies worked closely with his Department during the Medicines and Medical Devices Review, and the rapid registration of COVID-19 vaccines and treatments. On behalf of our industry, members and Board, we thank him for his service and dedication to Australia. Medicines Australia hired him as a thankyou for tearing up years of prudent drug approval and testing while authorising a whole new mRNA drug industry with no testing. How could you read this any other way?

    Mr Comley: I’ll allow Professor Lawler to comment first and then I may come back. I do note the point Ms Balmanno made that the obligations for confidentiality and use of information are still retained even when someone has left the service.

    Prof. Lawler: Thanks for the question. I recognise that there are a number of underlying elements to your comments around testing and evaluation that I don’t think are necessarily the main thrust of your question. I would highlight that our interaction with Medicines Australia is predominantly through our very well publicised stakeholder engagement processes. We don’t interact directly with the board. We don’t receive lobbying approaches from board members of organisations. We haven’t received any lobbying approaches from Professor Skerritt. The decision—

    Senator ROBERTS: With respect, I’m not talking about the board interacting. I’m talking about a former senior member of TGA—the senior member; the head of the TGA—now being on the Medicines Australia board.

    Prof. Lawler: Working on the board. As Ms Balmanno and the secretary have highlighted, there are code of conduct provisions that relate to the lobbying activities of former senior employees. We’re not lobbied by Professor Skerritt. We interact with Medicines Australia as we do—

    Senator ROBERTS: I’m not talking about that. I’m talking about—

    CHAIR: Senator Roberts, you do need to allow Professor Lawler to finish his sentences. Professor Lawler, please continue.

    Senator ROBERTS: Sorry.

    Prof. Lawler: I may be incorrect in this, but I’m taking that there is undue influence being applied to the decisions of the TGA by a former senior leader of that organisation?

    Senator ROBERTS: No, that’s not what I’m—

    Prof. Lawler: Sorry. I would ask for clarification then.

    Senator ROBERTS: My question is: is his appointment a reward for work he has done in the past?

    Prof. Lawler: Thank you for the question. The decisions that are taken by Medicines Australia on who does or does not sit on their board are questions for them.

    Senator ROBERTS: It certainly doesn’t look good. It looks like he’s being rewarded for things he’s done for them in the past when he was head of the TGA. The Chief Executive Officer of Medicines Australia is Ms Elizabeth de Somer. Is this the same person who was a member of your Health Technology Assessment Policy and Methods Review reference committee, which is a paid position responsible for: … ensuring that our assessment processes keep pace with rapid advances in health technology and barriers to access are minimised. That’s from your website. Barriers to the entry of her products. Are we paying the pharmaceutical industry to promote pharmaceutical industry agendas to neuter our approval process? This is not looking good.

    Mr Comley: I will ask Ms Shakespeare to comment.

    CHAIR: Senator Roberts, I do ask that you direct things to the officials as questions. It’s reasonable to ask questions of them.

    Senator ROBERTS: I did. I said, ‘Barriers to entry of her products’—

    CHAIR: My hearing of it was that it was a statement, given how you finished.

    Senator ROBERTS: My last words were a statement, but my question was: are we paying the pharmaceutical industry to promote pharmaceutical industry agendas to neuter our approval process?

    CHAIR: Followed by a statement. Please continue; I just remind you to please direct things as questions.

    Mr Comley: I will throw to Ms Shakespeare, but I’ll make a general comment that, where we, or other departments within government, are supporting reviews of policy matters that affect a range of stakeholders, it’s not uncommon for those stakeholders to be part of that review process. It’s also not uncommon for those stakeholders to be very clear when people declare what conflicts of interest they have and that people be aware of that. But there is a real balance here in having appropriate expertise in the room, including of what will happen on the ground, with making that policy process. Most of those reviews—almost all that I can think of—are never the final decision-maker. They make an input to government decision-making which is informed by their experience on the ground. Ms Shakespeare may have some further information.

    Ms Shakespeare: Ms de Somer, who’s the Chief Executive Officer of Medicines Australia, is a member of the health technology assessment review panel. The membership of the review panel was established under an agreement between the government and Medicines Australia, called a strategic agreement. She’s not paid for the work on that; it’s not a paid position. It’s a review led by an independent chair and it has other experts on it, including the Chair of the Pharmaceutical Benefits Advisory Committee. It has two consumer representatives, a government representative and also experts in health technology assessment.

    Senator ROBERTS: So the government has a—I’m sorry, continue.

    Ms Shakespeare: As Mr Comley said, the review is currently underway. It’s going to prepare recommendations to the government, but the government will decide whether or not it implements those recommendations.

    Senator ROBERTS: So the government has an agreement with Medicines Australia?

    Ms Shakespeare: We have a strategic agreement with Medicines Australia. We’ve got strategic agreements with a range of different groups.

    Senator ROBERTS: Where is the talk about ensuring safety across long-term use, which used to keep Australia safe for generations? Now it’s all about, it seems, not costing pharmaceutical companies money and approving killer drugs, like remdesivir and molnupiravir, that would never have been approved on a cost-benefit safety analysis before Professor Skerritt rewrote the rulebook. Are you aware of this?

    Prof. Lawler: Sorry, I’m struggling. There were two questions there, and I’m not quite clear on what it is that you’re asking. Are we aware of—

    Senator ROBERTS: Are you aware of Professor Skerritt’s involvement in approving antivirals molnupiravir and remdesivir, which are killer drugs, it seems—they’ve got very bad records overseas. What I’m saying is: rather than putting safety paramount, are the TGA and the department of health removing barriers to pharmaceutical company approvals?

    Prof. Lawler: I see. Thank you for the question, Senator. No.

    Senator ROBERTS: The patent cliff is a real problem—I’ll explain what that is in a minute—facing the pharmaceutical industry. Billions of dollars of sales are at risk as patents expire around the same time, producing a loss of revenue totalling $200 billion this decade for the pharmaceutical companies. MRNA technology, which has not been tested, will be the saviour of the drug industry, allowing drugs that are now off patent to be replaced with new mRNA drugs. I understand that in America they’re favouring two companies, one of which is Pfizer. That means the new drugs will be subject to patent, meaning profits all around—wonderful!—except for taxpayers.

    Minister, has your government—and the previous government—made a deliberate decision to allow patents on these novel mRNA products to save the profitability of the pharmaceutical industry over considerations of safety and financial cost to taxpayers?

    Senator McCarthy: I might start with acknowledging that Professor Skerritt did a commendable job in his previous role, and we certainly wish him all the best in what he’s doing going forward I think your questions place a slur on people’s character, and you might want to have a good look at that. People who move on, whether it’s in political life or in other forms of organisations, deserve the opportunity to move on.

    Senator ROBERTS: And I want to protect the taxpayer by making sure there are no conflicts of interest. You didn’t answer my question, Minister.

    Senator McCarthy: I’ll take your question on notice.

    Senator ROBERTS: I will repeat it. Has your government—

    CHAIR: Senator Roberts, you don’t need to repeat it. The minister’s taken it on notice.

    /2 Comments/by

    Pharma Exclusivity in TGA Processes a Barrier to Natural Products

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    Before a drug or natural therapy can be approved by the “regulator” — the TGA — it must have a sponsor whose job is to pay the license fee, fill out the paperwork, and prepare safety and efficacy reports. These can be overseas because we no longer require local trials for new drugs. Drug companies are happy to develop new drugs and sponsor the applications because they have 25 years to get their money back from the patent which gives them exclusive rights to the product’s profits. After that, a product can be ‘generic’ or off-patent and any pharma company can make it.

    Natural products such as cannabis and Aboriginal medicine from native plants cannot be patented which means nobody can afford to act as a sponsor. The result is the only thing doctors can prescribe are patented or ‘generic’ pharmaceutical drugs.

    I asked why there is not an office of the consumer advocate who can sponsor natural therapies like Cannabis and Albicidin (a natural antibiotic). Instead, the TGA chose to speak about their program to re-purpose pharmaceutical drugs that have already been approved for different uses. This answer really shows the pharmaceutical mindset our health administrators have. The legislation needs to be changed to give natural products a path to market.

    Transcript

    Senator ROBERTS: Thank you. That leads to another point. It opens it up from this one. We have a system that says that, unless a product has a sponsor, it will never be approved. This isn’t the TGA system. They don’t write policy. This is a department and minister problem. There are multiple studies on the efficacy of medicinal cannabis for some conditions, and yet they’re not listed in schedule 4. There are 150 substances in Aboriginal medicine, yet only two have been commercialised, because natural products, even with postprocessing, can’t be approved by your system, because, without a patent, nobody will sponsor the product. Minister, why is there not a public advocate within the department that can bring natural remedies to the people under poison schedules 2, 3, 4 under the PBS where appropriate? 

    Senator McCarthy: I will refer to the department. 

    Prof. Lawler : As you highlighted and as we’ve discussed previously, the act does require a sponsor to bring medicines for evaluation. There are a number of reasons for this, and not least among them is the fact that, once a medicine is listed on the Register of Therapeutic Goods, there is a need for postmarket surveillance, pharmacovigilance, and safety and quality assurance, so it’s obviously very important that there be a point of accountability for these medicines. We are undertaking some work in terms of a repurposing initiative, and I will ask Mr Henderson to speak to that. It is about ways in which some of the medicines that are currently on the market can be used in other ways and how that might extend beyond the current sponsorship arrangements. 

    Mr Henderson : As part of the last budget, the government approved funding of roughly $10 million over four years for the TGA to initiate a repurposing program for medicines. The context or the objective of that program is to incentivise sponsors—and non-pharmaceutical sponsors as part of that as well—to come forward with submissions to the TGA for medicines that are predominantly used off label. They are registered on the ARTG, the Australian Register of Therapeutic Goods, but for indications for which it may not have been feasible for low-population groups or niche population groups to have had a sponsor come forward in the past, so we’re looking to implement a program where we incentivise through waiving fees associated with the regulatory fees and charges as well as through working closely with our colleagues in the reimbursement space in relation to processes through the PBAC, pharmaceutical benefits and fee waivers. 

    Senator ROBERTS: Thank you. So there may be some hope. 

    CHAIR: We will return to this after the break. 

    /4 Comments/by

    The TGA are Administrators not Regulators

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    Until a few years ago, new vaccines and drugs were required to have local safety testing and went through a process that took years. This ensured a high degree of safety. During the COVID period, the Therapeutics Goods Administration (TGA) waved approvals through for new technologies (e.g. mRNA injections) and new drugs in a matter of months. Included in this new streamlined approval process were Molnupiravir and Remdesivir.

    Remdesivir was refused approval for 20 years owing to serious side effects in trials, including death. Molnupiravir also has a long history of failure. There are multiple studies out recently that show it is simply not effective against COVID, and yet this is the #1 drug on the Pharmaceutical Benefits Scheme. Australia spends $650m a year on Molnupiravir.

    I asked why we approved a drug with so much evidence showing negative efficacy and fatal outcomes, including cancer, to replace the Ivermectin + Zinc combo, which costs a fraction of the price and has been proven safe and effective across many years.

    I also raised the question of who supervises the supervisor — the TGA. “Nobody” was the response. That answer highlighted the overly cosy relationship between the international pharmaceutical movement and Australian pharmaceutical companies. The TGA requires further inquiry.

    A Royal Commission is the only institution in Australia with the powers of inquiry to understand how the TGA has gone from regulator to administrator, seemingly with none of the customary vigilance.

    Transcript

    Senator ROBERTS: My questions are to the TGA, and these questions go to the approval for molnupiravir. This is a drug developed in 2014 to treat encephalitis. It was then repurposed for influenza but was discontinued after concerns it was mutagenic. Merck then bought the company and used their influence with regulators—such as the TGA, apparently—to have the product approved as a treatment for COVID. This was on the back of a single trial where the preliminary results supported the application but the final results showed that, if anything, it had negative efficacy. Given the weight of evidence, in study after study, that molnupiravir has zero to negative efficacy, why is it still approved?

    Prof. Lawler: While one of our medical officers, Dr Kaye Robertson, comes to the table to respond, I would just highlight a couple of things. I take the comment that you made that the drug company used its influence on the TGA. There is a process that we follow, obviously, in the evaluation of all medications. Sponsors bring them for evaluation of safety, quality and efficacy, and that’s the process that is undertaken, rather than one of influence. I think it’s important to note that. In terms of the question you raised around why the medication is still approved for the indication that it has, I’ll ask Dr Kaye Robertson to respond to that.

    Dr Robertson: The TGA considered the evidence to support the approval of molnupiravir from the dossier that was submitted by the sponsor, in accordance with our standard processes, and drew the conclusion that, at the time, the benefits outweighed the risks. In terms of the specifics of any subsequent information that has been provided to the TGA, I am actually not in a position to comment with certainty. This is not the area I work in particularly, and I think we would be best advised, if the senator pleases, to take this question on notice and provide you with further detail.

    Senator ROBERTS: I appreciate your giving that offer and I will accept your offer for the question to be answered on notice. It does surprise me that approval was given on a single trial where the preliminary results supported the application but the final results showed that, if anything, it had negative efficacy. The weight of evidence, in study after study, shows zero to negative efficacy, so I’m amazed that it’s still approved. The approval required Merck to continue to provide ongoing safety data and testing around mutagenicity and interaction with the mRNA vaccines. Have they done that, and does the data justify retaining approval?

    Dr Robertson: I have before me the AusPAR that was published in relation to the studies that assessed the risk of mutagenicity. We can provide that to you in our response. I am reading from that, and it says: ‘Molnupiravir and NHC were mutagenic in the bacterial assay (with and without metabolic activation). Molnupiravir and NHC were not genotoxic in in vitro and in vivo micronuclei tests, and in vivo mutation assay at the cII locus (in Big Blue Transgenic F344 Rats). Equivocal results were obtained in an in vivo Pig-a mutagenicity assay … Carcinogenicity studies are not generally required for drugs for short term clinical use. However, the sponsor has initiated a short-term carcinogenicity in … mice.’ This was put to the clinicians on the ACM and other invited experts regarding this matter. It was considered at the time that, on balance, the drug remained to have a positive benefit-risk balance.

    Prof. Lawler: I thank Dr Robertson for that response. I’d also just add, Senator, that, because you’re asking for some quite specific currency and comprehensiveness of ongoing postmarket reporting, we’ll take that on notice and bring that information back to you.

    Senator ROBERTS: Thank you. In 2023 molnupiravir was top of the pops, Australia’s No. 1 drug, costing taxpayers $654 million last year, at $1,125 a prescription. Molnupiravir is 26 times more expensive than the out-of-patent ivermectin-plus-zinc combo, which is about $40 per prescription. And that’s what molnupiravir replaced—proven, safe and effective. Why are you spending $654 million—on something that is highly questionable as to its efficacy and its safety—when $25 million would have done?

    Prof. Lawler: I can’t speak to the specifics of the amount spent on molnupiravir, but I can certainly indicate that the second amount that you said—I didn’t catch the amount—

    Senator ROBERTS: The ivermectin-plus-zinc combo is $40 per prescription, and the total for the year would have been $25 million.

    Prof. Lawler: I think that the comparison is flawed, in that there is no credible, supportable evidence that ivermectin and zinc is an effective treatment. So I’m not convinced that you are—

    Senator ROBERTS: There is no credible evidence? There are 100 papers.

    Prof. Lawler: I’m not convinced that the comparison is sound.

    Senator ROBERTS: You based the decision on molnupiravir on one paper, and you’re ignoring 100 papers proving ivermectin’s success. Does anyone question the process—

    CHAIR: Sorry, Senator Roberts; I’m going to give Professor Lawler an opportunity to respond to that.

    Prof. Lawler: I didn’t hear a question.

    Senator ROBERTS: The question is this: does anyone question the TGA’s processes—

    Prof. Lawler: Yes.

    Senator ROBERTS: for approving drugs? How often do you evaluate them?

    Prof. Lawler: Drugs are—

    Senator ROBERTS: Who audits them? Is there an independent auditor?

    Prof. Lawler: I’m not sure which question you would like me to answer.

    Senator ROBERTS: All of them.

    CHAIR: Professor Lawler, are you clear on the question placed? There is a mixture of questions and assertions moving around here, so let’s just step back and, Senator Roberts, please place a question.

    Senator ROBERTS: The question is: how often do you scrutinise your process, and is there an external auditor who does that who is qualified to do it and to assess the process?

    Prof. Lawler: The processes that we follow are continually informed by our international collaboration and also by significant interaction with stakeholders, particularly the advisory committees that we have in respect of the assessments and evaluations that we undertake for products. We also undertake, obviously, the premarket review and evaluation of medicines and other therapeutic goods, and we undertake significant postmarket surveillance of the goods as well. We have outlined in significant detail on previous occasions the postmarket surveillance that we undertake. I might ask Mr Henderson to add to that.

    Mr Henderson: Senator, I think you asked about the number of submissions or medicines that we evaluate. Just for context, at the moment there are about 150 applications that the TGA is evaluating for both new medicines and changes to indications to current medicines.

    Senator ROBERTS: What is the point of telling me that?

    Mr Henderson: Sorry; I thought you asked that as part of your question.

    Senator ROBERTS: No, I didn’t ask for the number. Who are your stakeholders? Do they include the sponsors?

    Prof. Lawler: As a contemporary regulator, we have a broad stable of stakeholders. They do include industry. As with any regulator, we work to refine our processes to balance the appropriate observance of safety, quality and efficacy with appropriate access and streamlining processes to bring products to market with a minimum of inappropriate regulatory burden. We undertake annual stakeholder engagement surveys to understand the views of the TGA, and the three key stakeholder groups that we survey on an annual basis are industry; health professionals—and obviously it’s important we work with health professionals for a number of ways, in that they both inform us and are informed by our decisions—and the community. It is notable that the responses we get reflect that the TGA, among all groups, comes across as a recognised, understood and valued regulator in the Australian healthcare system.

    We have other stakeholders with whom we interact. We obviously interact very closely with the state health jurisdictions, and this is for a number of reasons. Our decisions on a number of elements, such as scheduling, for example, which we’ve already discussed today, have a significant impact on the state and territory poisons legislation and how they’re implemented for the delivery of medicines. We also interact quite closely with expertise across the regulatory sector. We have a number of advisory committees, the membership of which incorporates consumer views and expertise and also those from the academic and research sectors.

    It’s also important to note that we obviously have close relationships with our international collaborative regulators. We are part of the International Coalition of Medicines Regulatory Authorities and the International Medical Device Regulators Forum, and we also work closely with individual regulators such as the MHRA and the UK, European Medicines Agency and the FDA.

    CHAIR: Senator Roberts, I will shortly rotate the call to Senator Rennick and then can come back to you. Is this a sensible place to pause?

    Senator ROBERTS: I’ll make it a short one, and then you’ll come back to me. Spike proteins can enter the body in two ways in the context of COVID: from the virus itself and from the vaccines. What work has the TGA done on the health outcomes of the long-term retention of spike proteins by the body after the mRNA vaccines that you recommended? It’s been four years now, so some good old-fashioned science by the TGA must be available. Is there any assessment?

    Prof. Lawler: As has been indicated previously, as with all regulators around the world, we undertake a significant program of post-market surveillance and pharmacovigilance. This includes having a clear and well-communicated preference for adverse events post the vaccine to be reported. Those are reported and entered into our database of adverse event notifications, and, along with examination of that and also in collaboration with partner international regulators, we are very much aware and alive to emerging safety signals and act accordingly.

    Senator ROBERTS: But you haven’t done any studies on the retention specifically of the spike proteins? The COVID injections dramatically increased the spike protein. You haven’t done any studies of that?

    Prof. Lawler: I’m happy to have any additional response, but what I would highlight is that our role as a regulator is to assess evidence that is brought to us, and we undertake that assessment in the evaluation.

    Senator ROBERTS: So you don’t go looking for it?

    Prof. Lawler: We utilise that evidence in the assessment and evaluation of products, and we utilise the pharmacovigilance and post-market surveillance exercises that I’ve highlighted.

    /by

    TGA is Rubber Stamping Approvals

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    The Therapeutics Good Administration (TGA) has been established as an independent body to approve or reject applications for drugs, vaccines and medical devices. For many years, the TGA stood strong against pressure from the USA and pharmaceutical companies to shred our long-established approval processes that protected Australians from drug harm.

    Recently that pressure won out and the TGA has adopted the language of pharmaceutical companies, especially as used by their lobby group, Medicines Australia. The result has been the fast tracking of drugs and vaccine-like products that would not have been approved under the old system.

    I ask about the rate of approval -vs- rejection of drug applications. In the last 3 years, 140 drugs were approved. The Department dodged the question as to how many were rejected. Most likely this was because drug companies are allowed to withdraw their application rather than face rejection, so they can bring the application again. My information is less than a dozen applications have been “withdrawn”, suggesting the TGA is approving at a much higher rate than they have in the past.

    The actions of the TGA may have led to the spike in unexplained deaths and increases in serious harm to Australians. Only a Royal Commission will get to the bottom of their recent shift in process and the harm this may have caused to our health.

    Transcript

    Senator ROBERTS: I’m stunned that you wouldn’t study the long-term effects of COVID-19 spike proteins, given that the COVID injections cause the body to become a factory for the spike proteins. Let’s move on, though. The TGA website has a page entitled ‘Australian prescription medicine decision summaries’, which displays new drug approvals. 

    CHAIR: Before you go on, Senator Roberts, you just made an assertion— 

    Senator ROBERTS: I said I was stunned— 

    CHAIR: They may not wish to, but I want to check if anyone from the department or the TGA wants to respond to the preamble before your question. 

    Prof. Lawler : No, I don’t. Thank you, Chair. 

    CHAIR: You’re okay? Alright. Senator Roberts. 

    Senator ROBERTS: In terms of new drug approvals for calendar 2022, 2023 and 2024, three years—we’re in the third year—140 drugs were listed as approved. Is there a separate list of rejected applications? 

    Mr Henderson : We do publish the medicines that are under evaluation as well as the medicines that are approved. Medicines are either rejected or—a lot of times medicines are withdrawn by the sponsor. 

    Senator ROBERTS: Do you publish them? 

    Mr Henderson : No, we just publish the number of medicines that have been approved as well as the medicines that are under evaluation. 

    Senator ROBERTS: How many were rejected? 

    Mr Henderson : I’ll need to take that on notice for those periods. 

    Senator ROBERTS: Do you have a rough idea? 

    Mr Henderson : I don’t know— 

    CHAIR: If he’s taken it on notice, he’s taken it on notice. 

    Mr Henderson : I’ll take it on notice. 

    Senator ROBERTS: Thank you. Professor Skerritt was in charge of the TGA for most of that period. They approved 140 new drugs, and you don’t know how many have been rejected. Let’s go to plasmidgate. There were questions from several senators, including myself, at the last estimates relating to the scandal known as plasmidgate, which was the contamination of COVID injections with foreign DNA originating from E. coli bacteria used in the production process for making the COVID injections. Your answers on notice to all senators’ questions are essentially the same, which is ‘There’s no contamination,’ and you cast shade on the papers and persons who claim there is. Is this still your position? 

    CHAIR: That seemed to be quite a personal reflection in that question. Who particularly were you talking about? 

    Senator ROBERTS: There’s no personal reflection. It’s the TGA. 

    CHAIR: The TGA? 

    Senator ROBERTS: At last Senate estimates—and since, in answers to questions on notice. 

    Prof. Lawler : Again, I apologise for having lost track of the question. There were a number of elements there. Could you repeat the question for me, and I can get the best person here to answer it. 

    Senator ROBERTS: Sure— 

    Mr Comley : Sorry, the essence of the question is, ‘Do you stand by the answers you’ve given to questions on notice related to contamination?’ and the answer is yes, we do. 

    Senator ROBERTS: Okay. Have you tested a sample of these products in your own laboratory and have you personally assured yourself that there is no contamination in the COVID vaccines? 

    Prof. Lawler : Thank you for the question. All vaccines that have been released have been tested by the TGA and have passed. 

    Senator ROBERTS: How did you test the vaccines? Professor Skerritt told me he relied on the FDA, and the FDA said, before Professor Skerritt said that, that they relied upon Pfizer’s testing? What test did you do? 

    Prof. Lawler : Could I just clarify that you’re talking about batch-release testing. 

    Senator ROBERTS: I’m talking about COVID injections approval. 

    Prof. Lawler : I’m trying to clarify whether you’re talking about the release of vaccines for use. 

    Senator ROBERTS: I’m talking about the approval of the original COVID injections. Professor Skerritt told me that they were not tested here because you relied upon the FDA. The FDA had previously already stated that they did not do any testing; they relied on Pfizer’s testing, which was broken up. 

    Dr Kerr : Thank you for the question. We do do our own testing. 

    Senator ROBERTS: Did you test for contamination in the batches? 

    Dr Kerr : Yes, we do test for contamination in the batches, including for residual DNA. 

    Senator ROBERTS: And E. coli? 

    Dr Kerr : The E. coli can be determined through a test called endotoxin testing. We do test for endotoxins, and all of the batches that have been released into the Australia market passed the endotoxin test. 

    Senator ROBERTS: Attempts to examine batch-lot testing through freedom of information have resulted in documents that are 100 per cent redacted. I can flick the pages. You have the ability to put plasmid-gate to bed right now by publishing the results of your own testing without redaction. Will you provide to the committee that unredacted proof that there is no contamination? 

    Dr Kerr : We publish the summary of our test results on the TGA website. One of those tests is contamination, and I can confirm that the batches are not contaminated with residual DNA or endotoxin. 

    Senator ROBERTS: Thank you. Can we have a look at them? They’re on the website? 

    Dr Kerr : Yes. 

    Senator ROBERTS: I turn to blood clots. There’s an aspect of these injections that just doesn’t go away; in fact, it is becoming more common. Embalmers are reporting that bodies that they are embalming are affected by large blood clots. There are multiple videos and photos online. Dr John Campbell, a British doctor, did an excellent show recently on this. Have you looked at this issue? We know that it’s a problem with some of the injections. 

    Prof. Lawler : Taking on board the fact that it’s difficult for us to corroborate or validate some of the comments that you made, I’ll ask Ms Kay to comment. 

    Senator ROBERTS: I just want to know if you’ve looked at it. 

    Ms Kay : We have not confirmed an association between mRNA COVID-19 vaccines and thrombosis, or blood clots. We have released an extensive list of the safety investigations that we’ve undertaken in response to a question on notice. I can provide that to you again so that you can see which safety signals we have investigated. I can’t tell you off the top of my head right now whether blood clots is one of those. 

    Senator ROBERTS: Could you also tell me how you’ve done that evaluation? 

    Ms Kay : Right, okay. 

    Senator ROBERTS: You can take it on notice. 

    Ms Kay : I can tell you now, if you like, how we detect safety signals and investigate them. We have a number of different approaches to detecting safety signals. A key mechanism for detecting safety signals is the statistical analysis of the adverse event reports that we hold in our database, where we look for unusual patterns of reporting that might indicate a new safety signal. We then undertake a medical assessment of those safety signals, and that medical assessment will determine the need for further investigation. That further investigation then takes into account a broad range of different sorts of evidence. We’ll look, in detail, at the adverse event reports within our database, as well as looking at published literature and information released by other regulators. Those investigations assess the strength of the evidence for an association between an adverse event and a vaccine. Where we find a likely association, we’ll take regulatory action, such as updating the product information to make that information available to health professionals. 

    Senator ROBERTS: Can you tell me about the medical assessment? 

    Ms Kay : The medical assessment of those statistical signals? Certainly. It’s an accepted approach in pharmacovigilance to undertake what’s called a disproportionality analysis, where we look for signals of disproportionate reporting of a particular adverse event with a particular exposure—a medicine or a vaccine. It’s also accepted in pharmacovigilance that those statistical signals need to be put through a medical assessment to understand whether they might have arisen through bias or whether there may be a signal there that needs to be further investigated. There are quite a number of different aspects that are considered in that assessment, and I’d be happy to provide you with that information on notice. 

    Senator ROBERTS: Thank you very much. 

    /by

    Pharma Exclusivity in TGA Processes a Barrier to Natural Products

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    Before a drug or natural therapy can be approved by the “regulator” — the TGA — it must have a sponsor whose job is to pay the license fee, fill out the paperwork, and prepare safety and efficacy reports. These can be overseas because we no longer require local trials for new drugs. Drug companies are happy to develop new drugs and sponsor the applications because they have 25 years to get their money back from the patent which gives them exclusive rights to the product’s profits. After that, a product can be ‘generic’ or off-patent and any pharma company can make it.

    Natural products such as cannabis and Aboriginal medicine from native plants cannot be patented which means nobody can afford to act as a sponsor. The result is the only thing doctors can prescribe are patented or ‘generic’ pharmaceutical drugs. I asked why there is not an office of the consumer advocate who can sponsor natural therapies like Cannabis and Albicidin (a natural antibiotic). Instead, the TGA chose to speak about their program to re-purpose pharmaceutical drugs that have already been approved for different uses. This answer really shows the pharmaceutical mindset our health administrators have.

    The legislation needs to be changed to give natural products a path to market.

    Transcript

    Senator ROBERTS: Thank you. That leads to another point. It opens it up from this one. We have a system that says that, unless a product has a sponsor, it will never be approved. This isn’t the TGA system. They don’t write policy. This is a department and minister problem. There are multiple studies on the efficacy of medicinal cannabis for some conditions, and yet they’re not listed in schedule 4. There are 150 substances in Aboriginal medicine, yet only two have been commercialised, because natural products, even with postprocessing, can’t be approved by your system, because, without a patent, nobody will sponsor the product. Minister, why is there not a public advocate within the department that can bring natural remedies to the people under poison schedules 2, 3, 4 under the PBS where appropriate? 

    Senator McCarthy: I will refer to the department. 

    Prof. Lawler : As you highlighted and as we’ve discussed previously, the act does require a sponsor to bring medicines for evaluation. There are a number of reasons for this, and not least among them is the fact that, once a medicine is listed on the Register of Therapeutic Goods, there is a need for postmarket surveillance, pharmacovigilance, and safety and quality assurance, so it’s obviously very important that there be a point of accountability for these medicines. We are undertaking some work in terms of a repurposing initiative, and I will ask Mr Henderson to speak to that. It is about ways in which some of the medicines that are currently on the market can be used in other ways and how that might extend beyond the current sponsorship arrangements. 

    Mr Henderson : As part of the last budget, the government approved funding of roughly $10 million over four years for the TGA to initiate a repurposing program for medicines. The context or the objective of that program is to incentivise sponsors—and non-pharmaceutical sponsors as part of that as well—to come forward with submissions to the TGA for medicines that are predominantly used off label. They are registered on the ARTG, the Australian Register of Therapeutic Goods, but for indications for which it may not have been feasible for low-population groups or niche population groups to have had a sponsor come forward in the past, so we’re looking to implement a program where we incentivise through waiving fees associated with the regulatory fees and charges as well as through working closely with our colleagues in the reimbursement space in relation to processes through the PBAC, pharmaceutical benefits and fee waivers. 

    Senator ROBERTS: Thank you. So there may be some hope. 

    /by